About usdm
Usdm life sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their gxp technologies to accelerate growthOur deep domain knowledge and technology expertise in life sciences business processes are what sets us apartFrom strategy to implementation and adoption, we have delivered thousands of gxp projects globally.
As part of the usdm team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like microsoft, google, oracle, docusign, box, and many moreFrom molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for usdm’s clientsAre you ready to make an impact and drive real digital transformation in life sciences?
Founded in santa barbara in 1999, usdm has grown to a progressive, global company with 300+ remote employees and offices throughout the us, canada, and germany.
Job description
Usdm is seeking a drug safety db expert.
Primary responsibilities
Ensure that all safety reports received from any source (clinical trials and post-marketing), for assigned products and/or studies, are processed and reported according to ich-gcp guidelines, regulatory requirements and company sops, policies and procedures.
Ensure that all domestic and foreign safety reports received by client are appropriately triaged and scheduled in client safety database based on the following criteria: source, seriousness, data entry priority, initial vsFollow-up report.
Ensure consistency in the initial evaluation and assessment of incoming case reports and source documentation for completeness, accuracy,& legibility.
Exercise judgment and use knowledge of fda and ich guidelines and product labeling in performing initial case assessment for seriousness and expectedness / listedness.
Ensure appropriateness of meddra and who-dd coding performed by drug safety staff.
Track all cases in the workflow to manage departmental workload and to ensure adherence to processing timelines.
Assist with quality control reviews of others’ cases to ensure the accuracy, integrity and completeness of information entered into the safety database.
Liaise with assigned physicians in drug safety, clinical science and/or medsa to ensure that appropriate medical review and assessment is provided for assigned case reports.
Determine necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge.
Perform follow-up (telephone, e-mail or facsimile), as needed, either directly with reporter, through call center, or through appropriate cras, and documents results in case file.
Ensure that required follow-up for assigned cases has been completed.
Communicate with partner companies, collaborative sponsors and their respective clinical research organizations (cros) regarding the evaluation and processing of case reports.
Coordinates the distribution and submission of expedited and non-expedited individual case safety reports to regulatory authorities, partner companies, and other trading partners, as needed, to ensure compliance with regulatory and company timelines.
Qualifications
Argus expert
Strong project management skills
Some global knowledge of drug safety
Experience with axway or other database transfer systems
Education & certifications
B.sOr b.aDegrees
Working conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusiveReasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant messageMust be able to exchange accurate information in these situations.
Travel to client site for onsite work as needed.
Equal opportunity statement
Usdm life sciences is an equal opportunity employerAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this positionIt is not intended to include every job duty and responsibility specific to the positionUsdm life sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
